Rectal Cancer Anastomosis 4 Check Study

NCT ID: NCT04637061

Last Updated: 2020-11-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 287 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2023-06-01

Brief Summary

Anastomotic failure (AF), including anastomotic leakage (AL), increases morbidity and mortality after colorectal cancer (CRC) resection. An inadequate perfusion of the anastomosis or technical stapling defects may contribute to AF. Several studies evaluated the singular use of intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis. So far, a combined use of these methodologies, although acknowledged has not yet been tested as an indicator of postoperative AF or of intra-operative anastomotic repair in a prospective setting. This study aims to implement the intraoperative anastomotic assessment in a prospective series of patients undergoing rectal resection plus primary anastomosis for rectal cancer with or without ostomy, using a semi-quantitative check of 4 items (4-check). The procedure will include NIR-ICG-induced FA (to assess perfusion), air leak test and evaluation of the anastomotic donuts (to assess for the presence of technical defects). Included patients will be those scheduled for elective rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy. Primary outcomes will be the overall incidence of intra-operative anastomotic repair and the rate of post-operative AF. Secondary outcomes will be the overall incidence of adverse events and serious complications, the estimation of costs and resources, the operative time, hospitalization and post-operative measurement of inflammatory markers.

Detailed Description

All consecutive patients undergoing rectal resection (open and mini-invasive procedures) plus primary anastomosis for rectal cancer selected for the study will udergo a surgical intra-operative assessment of the anastomosis based on the check of the following 4 items (4-check):

1. Extra-luminal (serosa) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative assessment of the near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA).

2. Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative assessment of the NIR-ICG-induced FA.

3. Air leak test (extra-luminal and reverse).

4. Assessment of the anastomotic donuts. aiming to test the efficacy of the procedure (overall incidence of intra-operative anastomosis repairs) and the overall incidence of anastomotic failure

Conditions

Rectal Cancer

Keywords

rectal cancer; indocyanine green; fluorescence angiography; surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

REC4T study patients

Rectal adenocarcinoma or polyp with indication for resection and primary colo-rectal mechanical anastomosis using a circular stapler with/or without protective ostomy undergoing upfront surgery and patients undergoing neoadjuvant therapy followed by surgery (see Inclusion/Exclusion Criteria)

intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis

Intervention Type: COMBINATION_PRODUCT

Extra-luminal (serosa) and Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative NIR-ICG-induced FA. This will be conducted administering IV a bolus of 3.75 to 7.5 mg of ICG and evaluated using a Fluorescence Imaging System; following after completion of the anastomosis a second bolos of 3.75 to 7.5 mg of ICG will be administered IV and the anastomosis will be visualized by insertion of the system trans-anally. Colon and rectal segments and quadrants will be scored for any defect of perfusion.

Air Leak test

Intervention Type: DIAGNOSTIC_TEST

This will be conducted insufflaying air in the anastomosis through a proctoscope, tube or a flexible endoscope, after filling of the pelvis with saline solution and luminal occlusion of the intestine proximal to the anastomosis. Also, the anastomosis will be checked transanally for the presence of air leak.

Evaluation of the anastomotic rings

Intervention Type: DIAGNOSTIC_TEST

The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete

Interventions

intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis

Extra-luminal (serosa) and Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative NIR-ICG-induced FA. This will be conducted administering IV a bolus of 3.75 to 7.5 mg of ICG and evaluated using a Fluorescence Imaging System; following after completion of the anastomosis a second bolos of 3.75 to 7.5 mg of ICG will be administered IV and the anastomosis will be visualized by insertion of the system trans-anally. Colon and rectal segments and quadrants will be scored for any defect of perfusion.

Intervention Type: COMBINATION_PRODUCT

Air Leak test

This will be conducted insufflaying air in the anastomosis through a proctoscope, tube or a flexible endoscope, after filling of the pelvis with saline solution and luminal occlusion of the intestine proximal to the anastomosis. Also, the anastomosis will be checked transanally for the presence of air leak.

Intervention Type: DIAGNOSTIC_TEST

Evaluation of the anastomotic rings

The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Near Infrared Fluorescence angiography; indocyanine green

Eligibility Criteria

Inclusion Criteria

• 18 years or older.
• Rectal adenocarcinoma or benign polyp with indication for rectal resection with total or partial mesorectal excision and primary colo-rectal anastomosis with/or without protective ostomy.
• Patients undergoing upfront surgery and patients undergoing neoadjuvant therapy followed by surgery.
• Patients with adequate performance status (Eastern Cooperative Oncology Group Scale score of ≤2).
• Patient must sign the Informed Consent Form (ICF) before any study procedures and agrees to attend all study visits.
• Selection of the patient before inclusion.

Exclusion Criteria

• • Patient pregnant or suspected pregnancy.

• Patient with a comorbid illness or condition that would preclude the use of surgery.
• Past medical history of Inflammatory Bowel Disease (IBD).
• Synchronous cancers requiring extended sub-total or total colectomies.
• Long lasting therapy with steroids to be continued in the peri-operative period (4 weeks previous and 4 weeks after surgery).
• Use of antiplatelet drug (anti-aggregant) and/or oral anti-coagulant drug to be continued in the peri-operative period (1 week previous and 4 weeks after surgery).
• Patients assessed as American Society of Anesthesiologists (ASA) physical status 4.
• Patients with clinical stage of cT4b tumor after neoadjuvant theapy.
• Metastatic disease (clinical Stage 4).
• Patient undergoing emergency procedures.
• Planned colonic surgery along with major concomitant procedures (i.e. liver resections, other intestinal resections).
• Previous colon surgery (excluding appendectomy).
• Non-restorative procedures (i.e. Miles or Hartman resection).
• Colo-anal manual anastomosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roberto Persiani, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitarioa A Gemelli IRCCS

Central Contacts

Roberto Persiani, MD

Role: CONTACT

Phone: 0630154511

Email: roberto.persiani@policlinicogemelli.it

Laura Lorenzon, MD PhD

Role: CONTACT

Email: laura.lorenzon@policlinicogemelli.it

Other Identifiers

04101969

Identifier Type: -

Identifier Source: org_study_id